Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

NCT05430009 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 1652440
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases.

Conditions

Liver Metastases; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who receive all fractions of radiotherapy as planned

  Feasibility determination. Analyzed with descriptive statistics.

  Up to 0.5 years after start of study treatment

Secondary Outcomes (4)

• Proportion of patients who develop grade 3 or higher toxicity

  Up to 1 year after start of study treatment

• Progression-free survival

  Time Frame: Up to 3 years after end of study treatment

• Overall survival (OS)

  Time Frame: Up to 3 years after end of study treatment

• Proportion of patients with local control

  Time Frame: Up to 3 years after end of study treatment

Other Outcomes (1)

• Proportion of responders with increased frequency of circulating lymphocytes

  Time Frame: Up to 3 years after end of study treatment

Study Arms (1)

Arm 1

EXPERIMENTAL

This is an open-label, single-arm, single center clinical trial to evaluate the feasibility of liver SBRT (up to 4 metastases) during the first cycle of physician's choice ICI for NSCLC.

Radiation: Liver SBRT; Drug: Pembrolizumab

Interventions

Liver SBRT RADIATION

24-45 Gy delivered in 3-5 fractions to 1-4 lesions.

Arm 1

Pembrolizumab DRUG

200 mg every 3 weeks or 400 mg every 6 weeks

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years of age)
• Histologically or cytologically confirmed NSCLC with liver metastases
• Eligible for immune checkpoint inhibitors per treating medical oncologist
• Disease must be measurable per RECIST criteria
• ECOG Performance status of 0 - 2
• Adequate organ function per protocol.
• Allowable prior therapy includes adjuvant durvalumab, prior radiotherapy outside the upper abdomen.
• Patients must be willing and able to sign an informed consent form.
• Participants of childbearing potential willing to undergo pregnancy test and use contraception per Appendix.

You may not qualify if:

• Liver tumor burden which cannot be targeted with SBRT per treating radiation oncologist
• Presence of uncontrolled intercurrent illness or significant comorbidities precluding participation in a clinical study as determined by investigator
• Diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis).
• Other invasive malignancy active within 1 years, excluding in situ cancers
• Presence of psychiatric or substance abuse disorders that would interfere with compliance or safety
• Has a known history of active Bacillus Tuberculosis (TB), Hepatitis B or Hepatitis C infection
• Has received a live (active) vaccine within 30 days of enrollment.
• Active autoimmune disease that has required systemic treatment in the past 1 years aside from hormone replacement therapy (ie. thyroxine, insulin, or physiologic corticosteroid replacement therapy)
• Baseline corticosteroid use (\>10 mg prednisone daily or equivalent) at study entry
• Pregnancy or breast feeding

Sponsors & Collaborators

• VA Ann Arbor Healthcare System: lead
• LUNGevity Foundation: collaborator

Study Sites (1)

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Green, MD

  VA Ann Arbor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Green, MD

CONTACT

734-845-3914; Michael.Green4@va.gov

Shaneta Waddy, MHA

CONTACT

734-845-3914; Shaneta.Waddy@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Radiation Oncology

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: June 17, 2022
• Primary Completion: December 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)